Pfizer’s Abuse-Deterrent Oxycodone Gets FDA Advisory Committee NodBy
The US Food and Drug Administration (FDA) Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted in favor of approval of Pfizer’s ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride) extended-release capsules for its proposed indication, “management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.”
ALO-02 is an investigational oxycodone formulated with sequestered naltrexone technology designed to help deter oral and non-oral abuse when crushed. ALO-02 extended-release capsules contain pellets that consist of oxycodone hydrochloride, an opioid agonist, which surround sequestered naltrexone hydrochloride, an opioid antagonist. When taken as directed, the naltrexone is intended to remain sequestered and patients receive oxycodone in an extended-release manner. Studies demonstrate that when the pellets are crushed, up to 100% of the sequestered naltrexone is released and is available to counteract the effects of oxycodone.
The committees recommended the inclusion of abuse-deterrent labeling for intranasal and intravenous routes of abuse. They voted against inclusion of abuse-deterrent labeling for the oral route. The FDA will take the committees' recommendations into consideration before taking action on the new drug application for ALO-02.